The EDICT Trial - Therapy for Inflammatory Bowel Disease Flares

NCT ID: NCT07143188

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2026-06-30

Brief Summary

Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic inflammatory conditions of the gastrointestinal tract that affect millions of people in the United States of America. Among patients with IBD, symptomatic flares are quite common; up to 40-50% of patients in some populations report having a flare at least once per month. For most patients with IBD flares, the typical outpatient treatment consists of corticosteroids and, in some instances, initiation of or switching between 5-aminosalicylic acid-acid preparations, immunomodulators, or biologics. These treatments, while often effective, can have harmful side effects, especially when used for long durations of time. Therefore, alternative treatments are highly sought after by both patients and providers.

Detailed Description

Enteral nutrition (EN) has shown promise in treating IBD and has the theoretical benefit of reducing symptoms and increasing quality of life while avoiding the side effects associated with standard pharmacotherapy. Exclusive EN has even proven superior to steroids for induction of remission in CD in pediatric patients. Unfortunately, the same effect has not been seen in adults, but a Chochrane metaanalysis showed no significant difference in remission rates between steroids and exclusive EN for treatment of CD. Notably, however, EN studies are notoriously hindered by small group sizes and limited adherence to study diets due to poor palatability. Therefore, although exclusive EN may have a role in IBD treatment, there is limited data to support its use.

Elemental diets (ED) are a form of enteral nutrition in which free amino acids, mono- and polysaccharides, short or medium chain triglycerides, vitamins, and minerals are combined to provide a complete nutritional source. EDs have a long history of use in treating inflammatory diseases of the GI tract, such as IBD, eosinophilic esophagitis, and small intestinal bacterial overgrowth. The hypothesized benefit of EDs stems from their highly efficient absorption that requires minimal digestion, as well as the absence of allergenic antigens. As with other EN studies, examining the use of EDs for treatment of inflammatory gastrointestinal diseases have been limited by very poor palatability.

mBIOTA is a palatable elemental diet formulation that may be a more acceptable treatment option for a variety of GI problems. In a head-to-head comparison survey, mBIOTA outperformed its leading market competitor in six palatability domains (taste, smell, consistency, aftertaste, appearance, and impression). In a recently published study investigating ED for treatment of small intestinal bacterial overgrowth, subjects had a 100% adherence rate to mBIOTA supplementation during the trial period. Given its improved palatability compared to its predecessors, mBIOTA could prove useful as a new therapeutic tool in the treatment of inflammatory bowel disease.

Conditions

Inflammatory Bowel Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

elemental diet (ED)

The intervention in this study will be an elemental diet (ED) formulation produced by mBIOTA. All patients randomized to the ED arm will receive a two-week supply (84 servings + additional packets as needed) of the "original" flavor mBIOTA elemental diet.

Group Type: EXPERIMENTAL

elemental diet (ED)

Intervention Type: DIETARY_SUPPLEMENT

mBIOTA is a palatable elemental diet formulation

control group

Patients randomized to the control group will undergo counseling with a registered dietician for general dietary advice but will be instructed to continue their usual diet, as tolerated, without any restrictions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

elemental diet (ED)

mBIOTA is a palatable elemental diet formulation

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

mBIOTA elemental diet

Eligibility Criteria

Inclusion Criteria

• adults with an established diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease) who are being treated in the outpatient setting for an Inflammatory bowel disease (IBD) flare, defined as a clinically significant increase in IBD symptoms (e.g., abdominal pain, nausea, vomiting, diarrhea, joint pain, fever, bleeding, unintended weight loss).

Exclusion Criteria

• Patients requiring admission to the hospital for treatment of a flare
• Patients with allergies to any ingredients in the mBIOTA Elemental Diet
• Female patients who are pregnant
• Patients with diabetes who are taking insulin as part of their treatment plan
• Patients with other medical conditions or personal preferences that would compromise their ability to adhere to the elemental study

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

mBIOTA

UNKNOWN

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard B Weinberg, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Central Contacts

Bradley Joseph, MD

Role: CONTACT

bradley.joseph@advocatehealth.org

703-463-1287

Richard B Weinberg, MD

Role: CONTACT

Richard.Weinberg@advocatehealth.org

704-355-2000

Facility Contacts

Bradley Joseph, MD

Role: primary

bradley.joseph@advocatehealth.org

703-463-1287

Richard B Weinberg, MD

Role: backup

Richard.Weinberg@advocatehealth.org

704-355-2000

Other Identifiers

IRB00126650

Identifier Type: -

Identifier Source: org_study_id